Becker's Healthcare November 21, 2023
The FDA issued a final rule Nov. 21 that will require drugmakers to clearly state side effects and contraindications in direct-to-consumer advertisements. The rule is effective May 20, 2024.
The rule specifies five standards that drugmakers should follow to ensure consumer ads for prescription drugs meet this requirement, referred to as the “major statement”:
1. Information must be presented in “consumer-friendly language and terminology that is readily understandable.”
2. Audio information must be “at least as understandable as the audio information presented in the rest of the ad” when going over risks and contraindications.
3. For TV ads, the audio portion of the major statement must be presented alongside a text version “for a...
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